| Primary Device ID | 08904428745333 |
| NIH Device Record Key | f43ac4c9-6b65-49fd-bd2d-4f12d0705fbe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSEOUS- Skin Preparation Pad |
| Version Model Number | EA91062 |
| Company DUNS | 930270428 |
| Company Name | EON MEDITECH PRIVATE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 25 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 0 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08904428721405 [Primary] |
| GS1 | 08904428745333 [Package] Contains: 08904428721405 Package: Laminated Box [50 Units] In Commercial Distribution |
| NEC | Bandage, Liquid, Skin Protectant |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-23 |
| Device Publish Date | 2026-03-13 |
| 00890446104932 - OSSEOUS-Endoscrub 4 mm ( 0° ) | 2026-03-23 The Endo scrub is a single-use, sterile, accessory device designed for use with rigid endoscopes. It is a surgical tool, a devic |
| 08904428745326 - OSSEOUS- Skin Closure Tape | 2026-03-23 |
| 08904428745333 - OSSEOUS- Skin Preparation Pad | 2026-03-23The Skin preparation pad are single use tracheostomy pads that provide protection between the tracheal cannula and the skin and absorb secretions. It enlarges during use. If due to this it slips off the tube or tears easily it is worn out and needs to be replaced. Provides a protective layer between skin and adhesive Alcohol-free and used after cleaning the skin, before applying an adhesive. |
| 08904428745333 - OSSEOUS- Skin Preparation Pad | 2026-03-23 The Skin preparation pad are single use tracheostomy pads that provide protection between the tracheal cannula and the skin and |
| 08904428798421 - OSSEOUS- ShowerProtect | 2026-03-23 Shower guard is used to temporarily replace the HME during showering. |
| 08904428798438 - OSSEOUS- NeckFit Tube Holder | 2026-03-23 Made with soft foam and comfort fabric. Can be easily attached to the rib of laryngectomy tube or button. Dual-piece special des |
| 08904428798483 - OSSEOUS- Tube Cleaning Brush - 8mm | 2026-03-23 The tube cleaning brush is used to clean Laryngectomy tube &Laryngectomy button |
| 08904428798469 - OSSEOUS-Cleaning Pad | 2026-03-23 |
| 08904428799749 - OSSEOUS- Adhesion Remover Pad | 2026-03-23 The Adhesive removal pad are single use tracheostomy pads that provide protection between the tracheal cannula and the skin and |